State receives complaint about pharmacy tied to meningitis outbreak

Originally published October 26, 2012 at 7:47 pm

Updated October 26, 2012 at 10:01 pm

There are no compounding pharmacies in Washington state that operate on the same scale as the New England Compounding Center, the source of spinal injections that have killed more than two dozen people and sickened hundreds.

Washington has compounding pharmacies, but none approaching the “manufacturing” scale of business apparently done by the New England Compounding Center in Framingham, Mass., whose injectable drugs are under suspicion in more than two dozen deaths

None of the recalled lots manufactured by that company, licensed in Washington as an out-of-state pharmacy in 2003, were shipped to Washington, state Department of Health officials say.

But the state is now investigating a complaint against the company. The nature of the complaint was not disclosed, as is customary at this stage.

The complaint was filed after an outbreak of meningitis that has spread to 18 states and sickened 338 patients who received spinal injections of a steroid made by the company, mostly for pain. Federal health officials say unopened vials of the fluid contained a fungus.

The investigation of the New England Compounding Center (NECC) has brought to light gaps in oversight by state and federal regulators.

In general, state pharmacy boards license pharmacies and their workers, but the federal Food and Drug Administration (FDA) takes over when it can be determined that a company has become a manufacturer.

Any licensed pharmacist can compound ingredients, and many do, from time to time. For example, it might be that a child needs a medication in a liquid form, but the drug only comes as a capsule. Or several ointments might be combined for a patient with a skin condition of unknown or multiple causes.

In most cases, compounds are made for specific patients with a specific prescriber, although pharmacists may also mix batches for use by doctors’ offices or hospitals.

For example, Craig Toman, the managing member of Sound Prescriptions, which does business as Custom Prescriptions in Bellevue, says his pharmacy mixes a latex-packaging-free injection for a local dentist with a patient with a severe allergy.

Donn Moyer, spokesman for the state Department of Health and Board of Pharmacy, said there are no compounding pharmacies in Washington doing the volume that NECC was doing, “which would qualify as ‘manufacturing.’ “

Kelley-Ross pharmacy, in business since the 1920s, compounds ingredients in one of its four pharmacies. Although pharmacy-practice rules allow leeway, Ryan Oftebro, a pharmacist and co-owner of the company said, the ethical and legal standards are clear. “Making diaper cream to be used at a hospital bedside is one thing. Doing a mass production of an intrathecal (spinal) injection is another.”

In addition to required state-licensing inspections, both Kelly-Ross and Custom Prescriptions have been accredited by the Pharmacy Compounding Accreditation Board (PCAB). The board does on-site evaluations, requires that pharmacies obtain ingredients from FDA-registered and/or licensed sources and reviews the pharmacies’ programs for testing compounded preparations, among other requirements.

Accreditation is voluntary, Oftebro says, but the PCAB standard “should help reassure both the public and the prescribers,” and many compounding pharmacies are now in the process of achieving the accreditation.

In general, pharmacists say there are several levels of risk involved in compounding ingredients, from simple creams and ointments, to sterile injections. At the very high end are spinal-fluid injections such as those produced by NECC.

Such injections, Toman said, require rigorous testing and processes to make sure sterilization is adequate.

“I don’t think there should be a facility in the United States anywhere that is not an FDA-regulated facility that pumps out 17,000 doses of anything,” Toman said. “As we’ve all seen, that’s something that can affect a tremendous amount of lives when something goes wrong.”